tv Sanjay Gupta MD CNN April 27, 2014 4:30am-5:01am PDT
watched the deadly overdoses to go up. that's why she's against federal approval of zohydro, a potent new pain killer. >> in the middle of a prescription drug epidemic and we thought that that was related to an upswing in prescriptions for these opioid analgesic drugs like long-acting oxycodone. >> reporter: according to the national institute of drug abuse, roughly 20% of americans have used prescription drugs recreationally. of those 14% became addicted. car crashes are no longer the number one reason people die accidentally in the united states. nowadays, it's actually prescription drugs. that's because on any given day, people take more than the recommended dose. mix and match or take medications not prescribed to them. maybe take pills with alcohol and all of it can make for a deadly dose. in fact, the most recent data shows 37,000 drug overdose deaths in one year. mostly accidental.
about 21,000 involve prescription drugs. and of those, 75% were painkillers. zohydro is pure hydrocodone, five times more than the strongest vicodin. not only that, it can be easily crushed and snorted. but let's not forget chronic pain is a huge issue, tens of millions suffer from it. patient advocates say there is a place for a drug like this. dr. perrone disagrees. >> as a physician, as a drug safety person, this is not the choice that's going to help our population. >> reporter: perrone sat on an advisory panel that voted against zohydro 7-2. against that recommendation, the the fda did agree to put it on the market.
it ka are carries a warning statement. the manufacturer said, quote, the fact is that zohydro er is a novel pain medicine that fills an important medical need. joining me from fda headquarters is commissioner dr. margaret hamburg. welcome to the program. thanks for being here. >> thank you. >> this whole issue seems to have stirred up a lot of controversy. zohydro, state of massachusetts tried to ban it, 30 state attorney generals have asked you to reconsider this approval. your own advisory panel voted 11-2 against it. what are we missing here? why are those folks wrong on this issue? >> well, i think this should not really be about a single drug. it really reflects the growing concerns about opiate addiction abuse, misuse and overdose, and the need to balance strong strategies to combat that serious public health problem with ensuring access to
important pain medications for. in need. i think there are a lot of misperceptions about this particular drug, zohydro. but i think what it really brings into focus is that we, as a nation, need to do a better job to combat the serious problem of opiate addiction. i hope that we can really work together to focus on what are the key drivers of that problem and what are the meaningful, enduring solutions. >> did it surprise you that your advisory committee -- again, a very knowledgeable committee -- was so against this? it wasn't equivocal. it was 11-2. >> that's an important question. i want to underscore that that advisory committee met at a point in time, indicating that they could understand the benefits for patients, but they were concerned about the overall safety in the context of the epidemic of opiate overdose addiction and abuse.
and what we did was after that advisory committee met, we actually put in place a number of really quite stringent safeguards and new labeling so that it's much more clear to the prescribing physician that this is a powerful opiate drug with addiction potential, that it's only to be used for severe pain that requires round-the-clock opiate treatment when other treatments aren't adequate, that they need to be very sure that this is the right drug for their patient and reminds them of the addiction potential and the need to monitor their patient. >> the headline, dr. hamburg, a lot of people hear is that pain killer abuse is a big problem. you just alluded to this. 80%, roughly, of the world's pain medications are consumed in the united states. the concern that you hear is that could zohydro, making zohydro available, could it make the problem worse?
what do you think? how do you answer that concern? >> well, i think we need to deal with the appropriate prescribing of opiates and we need to find better treatments than opiates for chronic pain. actually, fda is working very actively with the research community and with product developers to try to find non-opiate treatments for pain that are effective. >> what are the strategies, talking about opiate overdose and some of these horrifying statistics is making it so it couldn't be crushed, tamper resistant. it can be helpful, the abuse of oxycontin pretamper resistant went down after it was made tamper resistant. so, is it -- should we have made a zohydro tamper resistant version first before releasing it? >> sadly, at the present time,
the abuse deterrent technology is very much in its infancy and we are encouraging the research community and companies to develop new, better abuse deterrent technologies. at the present time there's only one drug out of about 30 of the extended release, long-acting opiates and there is none in the immediate release category that has demonstrated abuse deterrent formulation. so, we need to keep pushing on abuse deterrent technology and we're encouraging it and working with sponsors. and that's something that i hope we'll have down the road. >> dr. hamburg, i appreciate you being on the program. this is a very important issue for us as well. we've been reporting on this idea that, you know, accidental overdoses from these opiates is one of the leading causes of death in this country and this is a fixable problem. glad to hear that you're on the case.
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meet, it is their reality. ♪ 15-year-old austin mcclaire has always wanted to be part of the high school band but day-to-day his mom jen says it is becoming harder and harder to play. >> austin's arm function is getting worse. i can see him struggling to lift his drum sticks. >> reporter: austin has a severe form of muscular destiny known as duschene. it's the disease that jerry lewis has been raising money for, for the past 60 years. have you noticed anything over the last couple of years that's become more challenging? >> it's been harder to get in my bed and position myself. >> reporter: having one son with duchenne would be hard enough. for any mom. jen has two. austin and his younger brother, max. boys first lose the ability to
walk around the age of 10. most don't live past their 20s. but 12-year-old max seems to defy these odds. and jen believes it's due to an experimental drug. max began weekly infusion treatments of the drug 2 1/2 years ago, part of a small clinical trial of 12 boys. austin didn't qualify because he was already in a wheelchair. how much of a difference has it had in their lives? >> i think you're literally looking right now at the mother of two children with duchenne, one who is going to be the first child to survive the disease and one who is going to have the last child to die from it. >> reporter: since the trial started, all 12 boys have seen their symptoms start to stabilize, and there don't seem to be many side effects, but the fda still has not approved the drug. they say they want more evidence. would the fda say look, we're just not sure yet. this is part of why we exist, to be sure that it is safe. yes, it's been a two-year trial. but we have to follow these kids
out for more time. we're not sure how effective it is because, again, it's too small. >> we have said that we will accept the possible risk that this drug isn't as effective as we think it is five years down the line or some kind of side effect develops. but in the meantime, while they are not sure and while they are collecting more data, our kids are dying. >> reporter: frustrated with the process, parents like jen have become vocal advocates, pushing for this drug's approval. it's become a contest of the emotional stories of these children and parents versus the very drug approval process itself. >> i want to know that they understand what children go through in a clinical trial. >> reporter: finding therapies for rare or orphan diseases like duchenne can be difficult because of the small number of patients and the extreme progression of the disease. by definition, rare diseases have fewer than 200,000 cases in the country. in the case of duchenne, there are just 15,000. >> rare disease is such that if we don't get our children in clinical trials and get these drug out quickly, there's no
hope for these kids. >> reporter: if you were able to get this medication, what do you think it would do for you? >> i think it would help me be able to do -- be able to do the things i like and for it to be easier for me to do them, like play the drums. >> joining me now from washington is jen mcnary. you met her in the piece, austin and max's mother. the fate of this experimental drug has been in limbo for quite some time. just this week, the fda did lay out a road map for the company, to conduct more trials, to get the drug possibly to more children and potentially lead to its approval if the results pan out. jen, you and i had a long conversation about this. the new trial is not going to launch for a few months. when it does, first thing is first, will austin be able to get the drug, do you think? >> you know, the fda has allowed for a flexible trial design with no placebo, including non-ambulant children. so, in theory, austin fits.
again, we don't get special treatment. he will be in line with all the other boys that could possibly benefit from this drug. >> i had a chance to talk to austin. he's a smart kid. we talked about a lot of different things. have you told him this most recent news? does he know he may be a candidate? >> oh, yeah. the morning we got the news, it was 6:55 and actually, we were kind of thinking we were going to get some news because just the timing was right. and so christine, my boss, were at the house, waiting for the announcement to come out, waiting for the press release and austin was woken up to the news that the fda was moving forward and that he should be considered for a trial and if all goes well, you know, they could be dosing really, you know, by september. i would say at the latest. i'm hopeful it will be sooner. i feel like the fda has said that they can move forward as soon as possible.
as soon as they have drug i really hope that they're beginning to recruit and dose these children. >> i would have loved to have seen the expression on his face. i'm sure there was a big smile and he appreciated that. jenn, thank you for spending so much time with us. it's an important story to tell. appreciate you being on the program. >> thank you so much. up next, a once common danger was almost wiped out but is now on the comeback trail. it's dangerous stuff. it can kill and many doctors don't even recognize it. salesperson #1: the real deal is the passat tdi clean diesel
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. up until the 1960s, there were more than a half million people catching measles in united states every year. times change thankfully. thanks to vaccinations, hardly anyone my age or younger has seen a case of measles. the cdc just put out a new warning about an outbreak. stephanie elam has the latest. >> reporter: it may start with a fever or a cough, but a splotch chi red rash is its signature. >> you're infectious four days before you company develop symptoms. you may not know you're sick. >> reporter: many people in united states have never seen measles since it was all but eradicated over a decade ago. >> i've seen it. i know what to look for t. new physicians haven't seen it. part of the campaign is to make sure they know what to look for. >> reporter: in california, the number of confirmed cases has risen in the last couple years. so far this year 58.
in orange county alone the number of cases has skyrocketed. >> we have 22 cases in orange coun county. >> reporter: why the sudden outbreak? the reason is the growing number of parents refusing to vaccinate their children. last year in california, there was a 15% increase of people opting out of immunizations. in orange county, a 30% increase. >> is there any reason to support this idea that vaccinations could be dangerous to children? >> absolutely not. there are serious consequences to having -- getting the measles. >> reporter: here they are trying to spread the word faster than the virus that vaccinations work. >> the two immunizations, the mmr you get is almost 95% to 98% protective. >> reporter: there vice president been any new cases here in three weeks and more people are getting their shots. maria tells me she brought her children in for their
immunizations two days after hearing about the outbreak. >> education can over come these misperceptions. >> reporter: another reason for the outbreak is our shrinking world. according to the centers for disease control, 93% of the people diagnosed with measles in california contracted it abroad or from someone who just returned from overseas. >> measles is pretty prevalent in other countries. when you go and visit, you need to make sure you're immunized. >> reporter: the doctor says the majority of people opting out are in the more affluent parts of orange county. he's hoping through education their minds will be changed. stephanie elam, cnn, on county, california. >> i want to take a moment and drive home a very important point about vaccinations. take a look at this map and pay careful attention to where the meesal cases are around the world. this is not hard to see. in parts of the world where vaccination rates are lower, the number of cases can be higher,
exponentially higher. in the uk they've had several recent outbreaks. it's important to point out when you get a vaccine, you're not just protecting yourself, you're protecting others around you. so even a small drop in vaccination rates can lead to a large rise in cases. a lot of doctors have never even seen a case of measles. it's worth pointing out the main symptoms are fever, cough, conjunctivitis but also this very distinctive rash. severe complications can be infections in the lungs and the brain and that can be fatal. you have to make sure your kids are vaccinated. also, anyone born after 1956, if you did get vaccinated, when you see your doctor, you should ask them to make sure you're still protected. still ahead, a double-edged sword for college students. they're smoking fewer cigarettes. that's a good news. they picked up a new trend that could be even more toxic.
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this week the fda proposed its long-awaited regulations on e cigarettes. i want to remind you this is what they look like. you can tell it has a battery pack over here. this is the nicotine vapor over here. once it's connected together, you take a puff. it activates the battery and you get a nick teen vapor. the fda is saying we want to keep them out of developeding machines, keep these away from teenagers. there's also something else that caught my eye. the results go a little further. it would cover other tobacco products as well including hookahs. this may surprise you. 40% of u.s. college kids used a hookah last year alone. many college students believe it's safer than cigarettes.
hookah smoke can be just as toxic. this is a traditional hookah. the basin is filled with water, tok tobacco heated using charcoal, producing a smoke that moves up the chamber and is inhaled through the hose. you might hear that water filters out some of the cancer-causing toxins. that's not true. they're exposed to more than cigarette smokers. here is a number you won't forget, in a 60-minute hookah session, 100 to 200 times the volume of smoke. realize don't notice it because the water cools the smoke making it less irritating to the lungs. it is important to point out that the fda regulations flag the risks from hookah smoke. before we go today, i want
to tell you about something i've excited about. it's this neat interactive we've launched. ten ideas that are revolutionizing health care from the hop rating table to the kitchen table. if you want to learn more about this, head to cnn.com/healingthefuture. "new day" sunday continues right now with christi paul and victor blackwell. -- captions by vitac -- www.vitac.com sunday is upon us. we're so glad to be sharing it with you. >> this is "new day" sunday. >> we want to take you to see what is happening in vatican city right now. what a celebration and truly historic as two new saints are cannonized. these are live pictures from vatican city. you can see how many people are there. >> millions of people there. beyond the historical relevance, the pomp and circumstance, the spectacle is amazing. last hour, pope francis made his
way through the crowds, greeting the faithful who gathered to witness pope john xxiii and pope john paul ii become saints. we'll have more on that in a moment. first we want to start with the controversy getting attention outside the nba, the root of it, but the athletes, fans and politicians including president obama. today during his visit to malaysia he spoke out about the firestorm in the u.s. this man, donald sterling, the long-time owner of the l.a. clippers, he's at the center of this. the team is a contender for the nba championship. sterling is not the focus because of that, but instead because of some remarks he's accused of making, some racial remarks. >> very slander ous racial remarks. sterling's alleged comments, they're part of a conversation with his girlfriend made public by tmz and